Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization

Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization And Quality of Life After Cryoballoon Pulmonary vEin Isolation in Patients With Paroxysmal Atrial Fibrillation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03268707

Acronym

TRACE-AF

Enrollment

100

Registered

2017-08-31

Start date

2017-07-15

Completion date

2021-06-30

Last updated

2019-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Paroxysmal Atrial Fibrillation, Pulmonary Vein Isolation, Telemetry Monitoring, Cryoballoon ablation

Brief summary

A randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

Detailed description

The telemetric smartphone application includes a digitized medical record, a mobile ECG device and a 24-hour on call service by a cardiologist. The hypothesis is that the use of a telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon pulmonary vein isolation. Secondary endpoints are quality of life measurements, health care cost calculations and recurrences of atrial fibrillation after ablation. All patients will undergo ablation and will be randomized into two groups: 1) conventional follow up with outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with the smartphone application, a mobile ECG device (patients will be able to send in as many ECGs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as well as outpatient visits 6 and 12 months after cryo-ablation.

Interventions

DEVICETelemetric smartphone application

Structured follow up with a telemetric smartphone application

OTHERConventional follow up

Conventional follow up at physician practice

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 18 years * Written informed consent * symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months prior to ablation) * cryoballoon pulmonary vein isolation * possession of a compatible smartphone

Exclusion criteria

* Age \< 18 years * persistent or permanent atrial fibrillation (AF) * prior catheter or surgical ablation of AF * pregnant females * contraindication for oral anticoagulation * manifest hyper-/hypothyroidism * no intention to cooperate * alcoholism

Design outcomes

Primary

Measure	Time frame	Description
Rehospitalization Recurrence of AF	in 12 months follow up	Rate of rehospitalization after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation, Recurrence of sustained atrial fibrillation (\>30 seconds) after atrial fibrillation ablation

Countries

Germany

Contacts

Primary ContactMelanie Gunawardene, MD

m.gunawardene@uke.de004940741054120

Backup ContactChristian Meyer, MD

chr.meyer@uke.de004940741054120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026